Eu legal requirements on food allergen labelling

All food businesses operating in the European Union (EU) need to comply with legislation on the management of allergens in food. This also applies to businesses that wish to export to the EU or other countries in Europe that have implemented EU laws.

The labelling legislation for allergenic foods is based on recommendations from the Codex Alimentarius Commission Committee on Food Labelling, which sets the standard for labelling in many other areas of the world. The EU regulations still apply in the UK during the Brexit transition period.

The EU Labelling Directive

Regulation (EU) No 1169/2011 on the provision of food information to consumers, and its amendments, is the only piece of EU legislation that specifically refers to allergenic foods. The law has been effective in EU countries since December 2014.

The key changes with regards to allergens included:

  • Improved legibility of information (minimum font size for mandatory information).
  • Clearer presentation of allergens for prepacked foods (emphasis by font, style or background colour) in the list of ingredients.
  • Mandatory allergen information for non-prepacked food, including in restaurants and cafes (previous legislation only covered prepacked foods).
  • Same labelling requirements for online, distance-selling or buying in a shop.

The two most important amendments to the Directive are:

  • The introduction of Annex II, which is a list of 14 substances or products causing allergies or intolerances that must always be labelled when present in a product.
  • The scientific panel responsible for food allergies provided a number of opinions as the scientific basis for the labelling legislation and exemptions from it.

Many countries have created national guidelines to aid the food industry in how to manage and label allergens including cross-contact allergens.

In the section on food manufacturing you can read about how food authorities in different countries recommend management and labelling of products that may contain small amounts of allergens because of cross-contact.

Allergenic foods in Annex II

As a result of the provision of food information to consumers regulation, you always have to label the allergenic foods listed in Annex II or any product derived from these foods (and products thereof):

     

  • cereals containing gluten, (i.e. wheat, rye, barley, oats, or their hybridized strains)
  • crustaceans
  • eggs
  • fish
  • peanuts
  • soybeans
  • milk (including lactose)
  • nuts (including almonds, hazelnuts, walnuts, cashews, pecan nuts, Brazil nuts, pistachio nuts and macadamia nuts)
  • celery
  • mustard
  • sesame seeds
  • sulphur dioxide and sulphites at concentrations of more than 10mg/kg or 10mg/litre expressed as SO2
  • lupin
  • molluscs

Examples of what this means in practice:

  • Sulphite levels above 10mg/kg in the ready-to-consume product must always be mentioned on the ingredient label, even if sulphites were not added intentionally into the finished product. Alcoholic beverages are not exempted from this labelling and therefore the sulphite used in their production must be declared as well.
  • Ingredients used as processing aids, like egg white in wine production and lactose as a carrier substance for flavours must be listed.
  • If the source of a vegetable oil or a flavour is a food listed in Annex II it must be specified on the label unless it is permanently exempted from allergen labelling.
List of exemptions from allergen labelling

Some products made from the allergenic foods in Annex II have been permanently exempted from allergen labelling based on opinions from European Food Standards Authority  (EFSA).

These products are not likely to cause severe allergic reactions as they only contain trace amounts of protein. The effect of the exemptions is, for example, that you can choose to label fully refined soybean oil as just vegetable oil.

Cereals containing gluten

Products thereof permanently excluded:

  • Wheat-based glucose syrups including dextrose*
  • wheat-based maltodextrins*
  • Glucose syrups based on barley
  • Cereals used for making distillates or ethyl alcohol of agricultural origin for spirit drinks and other alcoholic beverages

 

Fish

Products thereof permanently excluded:

  • Fish gelatine used as a carrier for vitamin or carotenoid preparations
  • Fish gelatine or isinglass used as fining agents in beer and wine

 

Soybean

Products thereof permanently excluded:

  • Fully refined soybean oil and fat*
  • Natural mixed tocopherols (E306), Natural D-alpha tocopherol, natural D-alpha tocopherol acetate, natural D-alpha tocopherol succinate from soybean sources
  • Vegetable oils derived phytosterols and phytosterol esters from soybean sources
  • Plant stanol ester produced from vegetable oil sterols from soybean sources

 

Milk

Products thereof permanently excluded:

  • When used for making distillates or ethyl alcohol of agricultural origin for spirit drinks and other alcoholic beverages
  • Lactitol

 

Nuts

Products thereof permanently excluded:

  • Nuts used for making distillates or ethyl alcohol of agricultural origin

* And products thereof in so far as the process that they have undergone is not likely to increase the level of allergenicity assessed by the EFSA for the relevant product from which they originated.
 

Disclaimer: We aim to provide a concise background to the EU law, but we do not intend to provide detailed legal advice. Anyone requiring detailed legal advice must contact a properly qualified legal practitioner. While we have taken every care to provide accurate information, we cannot be held legally responsible for the content of these pages or for any misunderstandings or misinterpretations.